# K210634: MCL 31 Dermablate System

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Apr 13, 2022 after 406 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 515 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 519 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150140: MCL 31 Dermablate, Asclepion Laser Technologies GmbH (2015) Summary page 4.
- K152153: MicroSpot Handpiece, Asclepion Laser Technologies GmbH (2015) Summary page 4.

## Most influential descendants
- K252561: BTL-754FF (2026), 0 descendants of its own
- K241600: Dermablate (2024), 0 descendants of its own
- K213761: Joule diVa System (2022), 0 descendants of its own

## Indications for use
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Source page: https://510kreport.com/device/K210634
Methodology: https://510kreport.com/methodology